Bold Type Information

Medical device software development requires deep regulatory, technical, and cybersecurity expertise. You can trust Bold Type to develop usable, beautiful, and functional software that is secure and meets FDA’s requirements. Our custom approach leverages a "Foundation App" that includes key features required in most medical device apps: secure Bluetooth connectivity, user authentication, onboarding, cloud data transfer, and over-the-air software updates. For a modest fixed fee, we customize and deliver this app in a few weeks with your logo and color scheme along with a physical emulator to support demos and development. From there, we can add a host of features at a super competitive hourly rate. In the end, you get a multi-platform (iOS, Android, web, etc.) app that is FDA compliant and secure. And you get all of the design history file documents needed to support your FDA submission from a company that is ISO13485 certified.